Our client, a leading medical device company based here in Galway is looking for a Supplier Quality Engineer to join their team on a 12-month contract.
In this role you would be working with external suppliers as well as within a cross functional team to resolve supplier related issues. This person would be a driving continuous improvement while also driving key quality metrics across the Galway location.
- Communicate with management and project team about supplier performance.
- Support in review of supplier introduction and changes, coordinating activities with suppliers as well as cross functional teams to develop and implement appropriate strategies to qualify and support.
- Provide expert QE technical direction input to component qualification strategies.
- Ensure appropriate controls are in place at supplier based on risk associated with product or service.
- Develop and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure GMP and quality standards are met.
- Define receiving inspection requirements as required and associated test method validation for all internal test methods.
- Bachelor’s Degree in a relevant technical discipline such as Engineering or Science or another technical field.
- Minimum 5 years relevant experience.
- The ideal candidate is a team player with excellent communication skills both verbal and written.
- Knowledge of regulatory requirements and guidelines including 21 CFR parts 210,211, 21 CFR part 820, ICH requirements and ISO 13485 is an advantage.
- Previous experience in Supplier Quality would be an advantage.
- ISO 13485 Lead Auditor Certification would be an advantage.
If you would like to discuss this role, reach out to Rebecca O'Connor on 091 749265 or email email@example.com
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